USA - AAFCO/FDA Reinstate the AAFCO Informal Review Process of Feed Ingredients
The Association of American Feed Control Officials and FDA have reinstated the decades-old AAFCO Informal Review Process or IRP with some changes. FDA had announced at the AAFCO Annual Meeting in Portland, Ore. that it was suspending the process but would complete those applications already in process.
The reason stated for the suspension was related to the requirement in the Food and Drug Administration Amendment Act of 2007 that requires FDA to create pet food “ingredient standards.” The American Feed Industry Association (AFIA) expected FDA would adopt the AAFCO Official Publication, but it appears that was precluded by FDA’s attorneys’ decision that such adoption would not be legal and, in fact, decided that the process of creating the ingredient definitions in the OP should not continue due to the large number of regulatory discretion letters issued.
In a meeting with the AAFCO Board of Directors the week of Oct. 18, FDA agreed to reinstate the IRP at AFIA’s urging for a limited time and under a different set of directions. In a notice from the AAFCO Ingredient Definitions Committee Chair Richard TenEyck of Oregon, the following broad statements were made:
•The IRP will function as before, but AAFCO ingredient investigators (not industry sponsors) will submit the ingredient data package to FDA’s Center for Veterinary Medicine (CVM) for review and concurrence.
•AAFCO will begin to consolidate current ingredient investigators to remove CVM employees that present conflicts of interest.
•AAFCO will educate investigators on how to identify a food additive submission and will create a food additive petition “lite” (FAP Lite) process.
•AAFCO will also educate its investigators on how to prepare a complete definition package for submission to FDA/CVM.
•The AAFCO OP will be edited to use FDA’s “Common and Usual” terminology
Moreover, AAFCO has formed a Board level task force to continue to review and refine this process.
Said AFIA VP Richard Sellers, “This is a major victory for AFIA members, as for several months it looked as if the AAFCO IRP would disappear. However, now FDA and AAFCO have taken AFIA’s strong objections to that disappearance seriously and are looking to rectify the situation and get back to the process that has worked so well for over 30 years.”
The AFIA Ingredient Approval and Definitions Committee will meet at AFIA offices Dec. 1 to discuss this process, develop a guide for AFIA members and meet with FDA scientists that supervise the AAFCO IRP review process.